US FDA drug chief resigns: Dr George Tidmarsh, head of the Food and Drug Administration’s Center for Drug Evaluation and Research, resigned two days after being placed on leave while federal officials reviewed “serious concerns about his personal conduct,” according to the Department of Health and Human Services.
HHS press secretary Emily Hilliard said the Office of General Counsel was notified of the issues on Friday; Tidmarsh stepped down Sunday morning. “Secretary Kennedy expects the highest ethical standards from all individuals serving under his leadership and remains committed to full transparency,” Hilliard said.
Also Read | US FDA clears first oral drug to cut heart risks in people with Type 2 diabetes
The departure coincided with a lawsuit filed the same day by Aurinia Pharmaceuticals, which accuses Tidmarsh of making “false and defamatory statements” while serving at the FDA and of using his position to pursue a “longstanding personal vendetta” against the company’s board chair, Kevin Tang. Tang previously sat on boards at several drugmakers where Tidmarsh was an executive, including La Jolla Pharmaceutical, and was involved in Tidmarsh’s ouster from those roles, the complaint says. Messages to Tidmarsh and his attorney were not immediately returned.
Tidmarsh, a longtime biotech entrepreneur and former Stanford adjunct professor, was recruited to the agency in July after meeting with FDA Commissioner Marty Makary. His brief tenure drew attention in September when he posted on LinkedIn that an Aurinia kidney drug “had not been shown to provide a direct clinical benefit for patients”, an unusually pointed public comment from a federal regulator about a specific product. Aurinia’s share price fell about 20% after the post, erasing more than $350 million in market value, according to the lawsuit; Tidmarsh later deleted the post and said he was speaking in a personal capacity. The complaint also alleges he targeted a thyroid medication made by American Laboratories, where Tang is board chair.
Tidmarsh’s exit is the latest turbulence at an agency already facing leadership churn and contentious decisions on vaccines, fluoride, and other products. The drug centre he led, the FDA’s largest division, responsible for reviewing and monitoring prescription and over-the-counter medicines, has lost more than 1,000 staff over the past year to layoffs or resignations, agency figures show. Earlier this year, Dr Vinay Prasad briefly resigned from his post overseeing vaccines and biologics before returning at the request of Health Secretary Robert F. Kennedy Jr.
Aurinia filed its suit in the US District Court for the District of Maryland and is seeking compensatory and punitive damages, saying it aims “to set the record straight.” The FDA and HHS have not disclosed details of the conduct review or who will serve as the acting head of the drug center.
